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A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use

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dc.contributor.author Kestelyn, E. en_US
dc.contributor.author Agaba, S. en_US
dc.contributor.author Van Nuil, J. I. en_US
dc.contributor.author Uwineza, M. en_US
dc.contributor.author Umulisa, M. M. en_US
dc.contributor.author Mwambarangwe, L. en_US
dc.contributor.author Ndagijimana, J. C. en_US
dc.contributor.author De Baetselier, I. en_US
dc.contributor.author Buyze, J. en_US
dc.contributor.author Delvaux, T. en_US
dc.contributor.author Crucitti, T. en_US
dc.contributor.author Jespers, V. en_US
dc.contributor.author van de Wijgert, J. H. H. M. en_US
dc.date.accessioned 2019-06-04T12:10:57Z
dc.date.available 2019-06-04T12:10:57Z
dc.date.issued 2018 en_US
dc.identifier.issn 1932-6203 en_US
dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0197572 en_US
dc.identifier.other http://lib.itg.be/pdf/itg/2018/2018ponee0197572.pdf en_US
dc.identifier.other 16 pp. en_US
dc.identifier.other 26 en_US
dc.identifier.other ITG-C8A; ITG-C9A; ITG-H10A; ITG-C11A; ITG-H12A; MULTI; DCS; U-CTU; U-ARLAB; DPH; U-MRA; U-HAP; JIF; DOI; PDF; PMC; OAJ; E-only; Abstract; ITMPUB; DSPACE65 en_US
dc.identifier.uri http://hdl.handle.net/10390/10306
dc.description.abstract BACKGROUND: Contraceptive vaginal rings could play a role in expanding the contraceptive method mix and in preparing communities for the introduction of HIV prevention and multipurpose rings. METHODS: We conducted an open label single-centre randomised clinical trial of intermittent versus continuous use of NuvaRing(R) in Kigali, Rwanda, in 2013-2014. We randomised 120 HIV-negative women 1:1 to intermittent use (three rings with a ring-free week in between rings) or continuous use (four rings without ring-free weeks). Women underwent an interview, counselling, and a speculum examination, and were tested for pregnancy, bacterial vaginosis (BV) by Nugent scoring, yeasts and trichomonads on wet mount, and sexually transmitted infections. FINDINGS: Only one woman withdrew early. Deliberate ring removals were rare, but spontaneous ring expulsions occurred during 14% of ring use periods. There were no incident pregnancies, serious adverse events, serious social harms, or early discontinuations for safety reasons. Systemic side effects were uncommon, and local side effects were not significantly differently distributed between groups except for lower abdominal pain (P = 0.013). The incidence of vaginal yeasts during ring use was high: 22% of intermittent users and 27% of continuous users had incident vaginal yeasts at one or multiple ring removal visits (P = 0.666), and symptomatic vaginal yeast cases were more common in the continuous than intermittent users (P = 0.031). In contrast, mean Nugent scores improved over time in both groups. CONCLUSIONS: Intermittent and continuous NuvaRing(R) use were safe in Rwandan women and improved Nugent scores over time. However, attention should be paid to ring expulsions and to a potential increased risk of vaginal candidiasis. en_US
dc.language English en_US
dc.relation.uri http://www.ncbi.nlm.nih.gov/pubmed/29856848 en_US
dc.subject Family planning en_US
dc.subject Contraceptive devices en_US
dc.subject Vaginal ring en_US
dc.subject NuvaRing en_US
dc.subject Safety en_US
dc.subject HIV en_US
dc.subject Viral diseases en_US
dc.subject Women en_US
dc.subject Rwanda en_US
dc.subject Africa-Central en_US
dc.title A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use en_US
dc.type Article-E en_US
dc.citation.issue 6 en_US
dc.citation.jtitle PLoS ONE en_US
dc.citation.volume 13 en_US
dc.citation.pages e0197572 en_US
dc.citation.abbreviation PLoS ONE en_US


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